The approval and licencing of medicines (and other regulatory activities) post Brexit

[user1471451327]

All you happy Leavers -explain to me why this man's explanation of the disaster that awaits us will not occur.....

threadreaderapp.com/thread/931546699033710592

"The UK has no structures or agency of its own for approving and licensing medicines. It relies almost exclusively on the European Medicines Agency. The MHRA is an ancillary organisation. In precisely 15 months UK access to the EMA ends; abruptly if the "no deal" voices prevail.
Where are the UK's preparations for replacing this vital framework? The answer is: Non-existent. Not even embryonic. Just a statement by Hunt this summer that the UK "will look to continue to work closely” with the EMA, but we're ready "to establish our own system if necessary".
The EU started planning to relocate the EMA (currently in London) the week after Art50 was notified to much tabloid chagrin, the idea that EU agencies should be located in the EU having come as a shock. That's just RELOCATING. We, who actually need to REPLACE it, have done nowt.
Having worked for a similarly sized gov't agency for most my professional life, I estimate that in order to "establish our own system" and have everything in place to take over March 2019, we needed to have started two years ago. And even that would be tight. I'm deadly serious.
The setting up will require complex, technical, primary legislation, which will be hotly contested between strong counter-pulling lobbies and interests (big pharma, NHS, patient groups, ethics cmtees) and require extensive consultation, expert advice and debate.
Only at THAT point, can you start looking for a CEO, a board, expert staff, support, training, a building etc. In all honesty, 15 months isn't even enough time if you were ONLY looking at the recruitment of such technical staff. Especially in such a niche area.
Then there's cost. Even by Eurosceptic estimates the UK pays a fifth of an agency like the EMA. It would need to set up the UK equivalent for a fifth of the cost just to break even. This is fantasy of course. Testing, assessing and licensing a new drug is inelastic, cost-wise.
This exposes the myth of "saving lots of money by leaving the EU". Much of the money we paid was to centralise essential tasks, like the medicines regime, with huge efficiency and time savings. Not dealing with multiple authorities also reduces costs for pharma cos, ergo prices.
This simple example also puts to bed any "they need us more than we need them" nonsense. Yes, we are an important contributor to the EU. Yes we are also an important market. They want us, for sure. But we need them. Structurally. Desperately. Not forever, but certainly now.
The day the UK leaves, everything in the EU27 will function PRECISELY as it does now. Money will be tighter. Some of their sectors will face challenges. But none of their rules or processes change. They face no transition. We do -in a myriad ways- and are totally unprepared.
Because medicines is only one of a 100 such regimes that need replacing which will fall on the same unfathomably stretched civil service to do; the same exhausted people trying to also do the other 99 things, as well as renegotiate 700 treaties, on TOP of their ordinary duties.
So, what happens if there's "no deal", in this, as in a thousand other areas for which the UK has simply made NO preparations? This isn't fluff. It's life and death. Sick people will end up waiting for years for available treatments, stuck in a bottleneck of unapproved meds.
Does your faith and patriotism have the magical power to make technical legislation and multidisciplinary agencies just spring into being? Is it unpatriotic to raise the #Brexit alarm or quite the reverse? Am I a remoaner for thinking about this? Or are you a fool for not?

END"

So is he right or wrong? Why?

[lljkk]

Will it be like countries that use the US $ for their currency, they don't print them & they don't regulate the supply or interest rate, they just coast along for the ride.

Could UK do that with medicines, just allow in anything that the EMA allows, and then never get around to own regulatory agency being established?

It's a kind of "sovereignty." We'd be choosing to save all that money that goes on regulatory testing.

[JumpingJellybeanz]

He's wrong. The magic brexit unicorns will sprinkle some rainbow glitter and all will be sorted. Then they'll skip off and do the same for radio-isotopes for cancer treatments.

[Carolinesbeanies]

Ill sprinkle some magic unicorn glitter....

He wrong OP. And purely because hes obsessing in a classic remainer fashion. The whole, 'UK are doomed' approach is more important than writing objectively.

Try this. (Cant believe Im linking to The Guardian!

https://www.theguardian.com/world/2017/sep/26/european-medicines-agency-relocation-could-cause-permanent-damage

Theres various options, but the obvious first one is, leave it where it is, either permanently or for the time being. The EU need to grow up instead of strutting round stamping their feet. But if thats utterly unacceptable to them on a point of pride then ;

Worse case scenario (according to said Gaurdian article, which on this occasion Ill take as wholly accurate ) the EMA may retain only 6% of staff. Where do you think the other 94% will go? My guess, once theyve changed the brass plate at the front of the offices, they may move a couple of feet to accomodate a few new office plants.

Their best case scenario they claim, is retaining between 60% and 80%. (Thats a little loose. Did the differing 20% ummmmmm and ahhhhhhhhh alot?)

The one question they didnt ask was, would you stay in London doing the same job but for the MHRA instead? Who knows what the answer would have been then.

The author ignores that the MHRA is already legislated for. It may require an extension of powers, or however they wish to organise it, but that really isnt beyond the wit of man. The staffing required is also less, possibly significantly less. How many new drugs coming to market, are aimed at specific eu nations? I dont know. I do know I get different drugs in France than I do here.

The author ignores its the EU who dont have offices, staff, etc currently, whilst the UK do, and whilst hes keen to point out the EU started "planning" the week after A50, its taken them this long to organise their 'eurovision bung' contest for next week, to whittle down a short list of new potential host cities. Clearly theyre not acting with urgency.

The author also ignores exactly the point Illk makes. Im a supporter of aligning with the US as I think it will massively reduce our national drugs bill. However dont be surprised if my point here about the US, then attracts the chlorine chicken brigade. We have a fair bit of anti-americanism here on MN.

Yes there will be some disruption, but nothing like the level the author is hoping for.

[Mistigri]

I think the likelihood is that the EMA can't be replaced and won't be - the govt will simply write legislation that enables drugs authorised in the EU to be licensed in the UK. It strikes me that there aren't any real alternatives in the time available.

The more interesting question is really the other way round - how will this affect clinical trials and pharma manufacturing in the UK once we are outside European structures. My DH who has a professional interest in this area thinks that a lot of this activity will simply move to the EU (which incidentally he thinks is a business opportunity for him, no "remoaning" going on here).

[Bolshybookworm]

Genuinely intrigued as to why you think aligning with the US will massively reduce our drugs bill, caroline. Regulatory bodies don't decide drug prices, drug companies do and in the US, where the health market is entirely driven by money (as opposed to need) they set them high. The body that massively reduces our national drugs bill is NICE, which negotiates with drug companies for a reasonable cost when a new drug becomes available. Often, they're negotiating with companies that have set prices based on the US market that are unjustifiable for a publicly funded health service like the NHS.

Here's a good example of the sort of shenanigans US drugs companies get up to- pulling a leukaemia drug so it can be marketed at vastly inflated cost to the more lucrative MS market.
www.cbsnews.com/news/genzymes-dilemma-its-cheap-cancer-drug-wants-to-cannibalize-a-potential-ms-blockbuster/

They did pull it btw.

[Bolshybookworm]

Also, don't forget that the MHRA already has an existing job, it can't just drop everything to replace EMA. Any changes to the way we run clinical trials, which are highly regulated, will be the responsibility of the MHRA and that will entail huge amounts of work.

As with everything Brexit related, none of this has really been thought about or planned for so we'll probably end up with some temporary bodge job and then, who knows. What an ill thought through, futile waste of time all of this is.

[Cailleach1]

Even if a new location doesn't retain the bulk of EMA staff, it will rebuild the complement needed. Core activities will be retained. However, it is probably more likely to locate to another attractive location and luring well educated, competent and experienced staff from 27 countries won't be a problem. Don't forget the Japanese letter details about their pharma companies being established in same place as the EMA location.

I think they will try to ensure approved medicines on sale the day of Brexit can still be legally sold in the UK. Also medicines manufactured in the UK on shelves of the 27 on day of Brexit can similarly be sold. Maybe ones already "imported" into the EU 27 as well.

The new location will benefit from 10's of thousands hotel bedrooms occupancy a year. Think of all the ancillary service jobs arising from that. As well as the new office space occupancy of Pharma company offices. This is on top of the highly educated workforce and their families. And eventually pharma manufacturing itself.

It will all be revealed who will benefit from Britain's loss. John Major bagged the EMA, I believe.

www.newstatesman.com/politics/health/2017/04/what-happens-when-european-medicines-agency-leaves-uk

[Cailleach1]

Who would have thought any subsequent group of politicians would make John Major and some of his contemporaries look like the creme de la creme? This present lot have.

[Cailleach1]

I'm laughing about the delusion about leaving it where it is being an option. It is an EU agency and will be established in an EU country. Why do you think London was a candidate location in the first instance? If outside countries were prospective locations, Washinton DC would make much more sense. US big pharma and the US regulatory FDA in the same place. But an EU country it will be.

It seems to kill Brexiteers that the EU still exists and will carry on after the UK leaves as a member state. Ireland will be screwed and will have a landmass between it and the other EU 26. I'd say the Brexiteers are satisfied to impact adversely on at least one country. Other member states not neighbouring the UK will be impacted much, much less. They have different neighbours and won't have an unfriendly, if not hostile landmass between them and the rest of the EU.

[justicewomen]

Of course the EMA will move, it is an inevitable consequence of us leaving not only the EU, but the single market and customs union.

Clearly the EU have done some extensive planning (if you know the outcome of staff questionnaires asking you about the likelihood of relocating to specific bidding locations, you have already done a lot of work). So why have not the UK?

And this applies to every EU regulated activity -food, transportation, uranium, banking...the list is huge. the fact that fishing, banking, regions like Cornwall etc are seeking special arrangements is very telling.

Carolinebeanies....why do you complain about a lack of objectivity and then use the sort of subjective term like the EU "strutting around stamping their feet". At worst the EU nations are behaving just no more or less nationalistically as UK leavers,. In reality they are mostly just following the logic of the UK wanting out and wanting the best commercial deal for the countries remaining in the EU.

The idea they should be "fair" (rather than commercially hard-nosed) to us is delusional...certainly the US ,China, Australia will be no more "fair" to us, and will cut a deal best for their populations/businesses, not ours.

Fairly soon, ordinary leavers/remainers will have to deal with the consequences of us leaving what was objectively a good deal. The rich leaver elites like Banks, Redwood, Farage, Dyson will just put their money /business elsewhere

[lonelyplanetmum]

I think the OP insight is entirely accurate and realistic.

The effect of losing the EMA is hugely significant.Of course,if that's the plan we will eventually be able to fund and staff our own expanded little MHRA or something new. But at what cost, delay and loss of prestige? Not to mention the loss of revenue from the business done and visitors attracted by the EMAs presence here.

So much better to have been leading the way as we were, based on pooled resources, mutual research and academic and regulatory co-operation. 

Also laughing about the delusion about leaving the EMA where it is as an option, you could equally argue that the US should base its FDA here. Or perhaps Russia would like to base its regulatory body here?

Other factors are:

1. Significant delays to the approval of new medicines. Canada and Australia regulate drugs nationally as we may have to. New medicines there come to market between six months and a year later than in the EU. So patients will be denied faster access to new medicines.

 2. Pharmaceutical companies will of course prioritise the much larger EU market. The loss of the EMA will  create a knock-on effect on investment and location decisions by global pharmaceutical companies, further chipping away at the UK economy. The Japanese have already indicated they'll vote with their feet.

1. The knock on effect on the pharmaceutical industry affects the  life sciences sector too (turnover of more than £60bn a year).

"  In 2014, it invested £4bn in research and development, more than any other sector, and it employs 220,000 people. In ... Cambridge alone, there are over 160 life sciences companies, reinforcing the local knowledge economy and contributing outside of the region as well. Indeed, Cambridge is one of just a handful of UK cities making a net contribution to HM Treasury, thanks in no small part to its vibrant life sciences." This is now at risk.

1. There's also a prestige impact. The EMA and the FDA are the leading bodies, Instead of providing a home to the largest one of these, we will now be small fry. Who will care what our little agency does or says?

Also After watching some of Louis Theroux's insights into the US pharma industry I'm not that keen on popping some US approved products down my throat to be honest.As confirmed by this, and many similar articles.
psmag.com/social-justice/how-big-pharma-gave-america-its-heroin-problem
https://hbr.org/2017/04/how-pharma-companies-game-the-system-to-keep-drugs-expensivee_

https://www.forbes.com/sites/matthewherper/2015/11/01/after-investigating-americas-heroin-epidemic-60-minutes-indicts-the-pharmaceutical-industry//_

https://psmag.com/social-justice/how-big-pharma-gave-america-its-heroin-problemm_

http://www.lohud.com/story/news/local/westchester/2017/09/29/westchester-sue-pharma-opioid-heroin/715662001//_

[lonelyplanetmum]

Having issues with links today but you get the gist.

[Peregrina]

Im a supporter of aligning with the US as I think it will massively reduce our national drugs bill.

So much for 'taking back control'.

[Peregrina]

I think history will be a lot kinder to John Major. It's not relevant to this topic, but he did a lot of the work for the Good Friday Agreement.

[Cailleach1]

I think that about John Major as well, Peregrina. If only the association with Edwina had never come out. He promoted the Back to Basics and family values which looks a little silly now. Can't take away his achievements, though. He stepped up to the plate on the British side.

[Carolinesbeanies]

So the circus begins.....

www.politico.eu/article/ema-eba-brexit-why-race-for-eu-agencies-is-more-complex-than-eurovision/

[justicewomen]

And the final sentence of that article Caroline is apt:

"One thing is for sure though — with the two lucrative agencies leaving its shores, on Monday the U.K. will be receiving null points."

[OliviaD68]

@Carolinesbeanies

Aligning with the US .... Here we go again with empty bullshit.

So pray tell us why aligning with the US on meds is a good thing? Why this helps us when we are currently 100% integrated with the EU?

Separately, please educate us on why our drug prices would be lower than they currently are given that US drugs prices are the HIGHEST IN THE WORLD. US DRUG PRICE CHARTS

You may not know this but it is illegal for the US govt to negotiate drug prices for Medicare recipients.

We are waiting to be enlightened.

[sundaysurfer]

Oh Caroline, you must know that the stuff you write is nuts ...

The EMA is a big agency, many EU member states want it because it’s very economically interesting (especially due to the pharmaceutical companies that cluster around it). Staff at the EMA would, presumably, rather stay where they are. As they can’t, they are lobbying hard for an attractive destination. Don’t worry though, if the EMA ends up in Dublin, Amsterdam, Lille etc. it will hang on to way more than 6% of its staff. It won’t collapse. It’s just moving. As are all the satellite pharmaceuticals.

There’s no circus, just some deals being done - deals between EU Member States with their own national interests, who all get VOTES. Fancy that.

[Peregrina]

But Caroline would sacrifice voting rights to be aligned with the US without voting rights. At least we know the position she is arguing from.

[OliviaD68]

@Peregrina

Great point.

It’s how we take back control you see. It’s sovereignty to have Trump decide for you.

[TheElementsSong]

It's only like all that boring expert stuff from liberal metropolitan elite Remoaners. ISTR, in a discussion about the impact on the UK's hitherto highly-regarded scientific research, one of our Brexiteer friends blithely explained that it would be no real loss because "we can just Google it".

[JumpingJellybeanz]

Confirmation just in that financial services are fucked, in case there's any doubt.

www.independent.co.uk/news/uk/politics/brexit-passporting-rights-banks-financial-services-michel-barnier-speech-talks-david-davis-a8064836.html